Beyond regulatory compression: confronting the liminal spaces of health research regulation

Abstract

Biomedicine and the life sciences continuously rearrange the relationship between culture and biology. In consequence, we increasingly look for a suitable regulatory response to reduce perceived uncertainty and instability. This article examines the full implications of this 'regulatory turn' by drawing on the anthropological concept of liminality. We offer the term 'regulatory compression' to characterise the effects of extant regulatory approaches on health research practices. With its focus on transformation and the 'in-between', liminality allows us to see how regulatory frameworks rely on a silo-based approach to classifying and regulating research objects such that they: (1) limit the flexibility necessary in clinical and laboratory research; (2) result in the emergence of unregulated spaces that lie between the bounded regulatory spheres; and (3) curtail modes of public participation in the health research enterprise. We suggest there is a need to develop the notion of 'processual regulation', a novel framework that requires a temporal-spatial examination of regulatory spaces and practices as these are experienced by all actors, including the relationship of actors with the objects of regulation.

Co-production and Managing Uncertainty in Health Research Regulation: A Delphi Study

“…The responses to the Delphi survey capture a core, recurrent theme that cuts across the regulation of health regulation, namely uncertainty [29,30]. Uncertainty, of course, can arise in multiple forms in this field; research by its very nature is an uncertain endeavour.…”

“…We can thus derive two sub-themes from the responses. First, inefficient legal responses to uncertainty [30] mean that those who fall within the rubric of regulatory rules are often left with various difficulties about how to navigate them. Second, some participants reported that the law is creating uncertainty for various 'partners' in the health research process, especially for researchers.…”

“…As noted above, requirements to report minor adverse events that are not necessarily relevant to the research aims can mean that critical tasks such as the collection of complete and high-quality baseline and outcome data-on which the reliability of the results depend-get neglected. This 'mismatch' between what clinical researchers see as contextually serious, and what the regulations define as necessary to report, can lead to clogged regulatory spaces and research projects tangled in a regulatory mire [30]; see also [18]. Participants voiced a preference that each step of the regulatory process be more carefully managed, with a view to bringing the research project to fruition-and then sustained through completion-as ethically and efficiently as possible.…”

“…It is not uncommon in the realm of human health research for regulators to adopt the 'command and control' model of regulation, as is commonly understood in regulatory theory [4,30]. This involves a centralised authority, usually wielding legal powers of inspection and sanction, to oversee an area of health research.…”

What Does It Mean to Take an Ethics+ Approach to Global Biobank Governance?

“…This article offers an analysis and a defence of such a model. Put otherwise, it represents a call to adopt a processual approach to regulation and governance (Taylor-Alexander et al 2016). As articulate above, such an approach focusses on the experiences of governing, both for those in such a role and for those subject to governance.…”